Summary
Carex is partnering with a Pharmaceuticals industry partner to identify a Supplier Quality professional responsible for ensuring that suppliers and contract manufacturers meet quality, regulatory, and compliance requirements. This role supports supplier qualification, monitoring, and continuous improvement across contract manufacturers, testing laboratories, and material suppliers involved in pharmaceutical development and commercialization. The position collaborates cross-functionally and engages with external vendors to uphold quality standards and regulatory expectations.
What You'll Do
- Manage Supplier Corrective Action Requests (SCARs) and Supplier Change Notifications (SCNs), ensuring timely assessment, resolution, and effectiveness.
- Guide and coach stakeholders on SCAR and SCN processes to promote consistency and strengthen quality culture.
- Support cross-functional evaluation of supplier changes and corrective actions, including impact assessments and follow-up activities.
- Oversee quality agreement lifecycle management, including drafting, reviewing, approving, and maintaining compliance with periodic reviews.
- Assist in establishing and tracking Supplier KPIs and contribute to Quality Management Reviews and Business Review meetings.
- Maintain current knowledge of regulatory requirements and compliance expectations related to drug development.
- Author, review, and maintain procedural documentation such as SOPs, work instructions, policies, and forms.
- Support regulatory inspections as a subject matter expert.
- Ensure compliance with cGMP, 21 CFR, USP, EP, and ICH standards.
- Perform additional responsibilities aligned with the role as needed.
What You'll Bring
- Bachelor’s degree in a scientific field.
- Minimum of 8 years of experience in pharmaceutical or biotechnology quality, including at least 4 years in supplier quality.
- Strong knowledge of FDA, EMA, ICH, GxP, and GDP regulations.
- Experience managing supplier quality systems, including SCARs and change notifications.
- Excellent communication skills with the ability to collaborate across diverse teams and external partners.
- Strong attention to detail, organizational skills, and a proactive problem-solving mindset.
- Experience with electronic document management systems in regulated environments preferred.
- Proficiency with Adobe Acrobat, Microsoft Office, DocuSign, and SmartSheet preferred.
- Ability to work independently, manage priorities, and operate effectively in a fast-paced environment.
- Strong interpersonal, verbal, and written communication skills with a professional approach to external interactions.
Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity, or Veteran status.
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